Pharmacogenomics: A new clinical or regulatory paradigm? European experiences of pharmacogenomics in drug regulation and regulatory initiatives

Drug Discovery Today

Volumn 16, Issue 19-20, 2011, Pages 867-872

  Prasad, Krishna ^a   Breckenridge, Alasdair ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PANITUMUMAB; PROTEIN TYROSINE KINASE INHIBITOR; ROFECOXIB; THIOPURINE METHYLTRANSFERASE; TRASTUZUMAB; TRIACYLGLYCEROL;

ANGINA PECTORIS; BREAST CANCER; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DYSPNEA; GENOME; HOME HEALTH AGENCY; HUMAN; HUMAN GENOME; ONCOGENE; PHARMACOGENETICS; PHARMACOGENOMICS; PROGNOSIS; REVIEW; SENSITIVITY AND SPECIFICITY;

BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; EUROPE; GENETIC TESTING; GOVERNMENT REGULATION; HUMANS; PHARMACOGENETICS; POLICY MAKING;

EID: 80053939993     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.08.016     Document Type: Review

References (20)

1. Editorial Biomarkers on a Roll Nat. Biotechnol. 28 2010 431
2. S.B. Shurin, and E.G. Nabel Pharmacogenomics - ready for prime time? N. Engl. J. Med. 358 2008 1061 1063 (Pubitemid 351347106)
3. At last, Axa pays for HerceptinThis is Money (http://www.thisismoney.co. uk/insurance/health/article.html?.id=39)
4. Revoking breast cancer drug will cost lives. Available at: http://www.sun-sentinel.com/health/fl-nbcol-breast-cancer-brochu-01225-20110125, 0,2869649.column
5. Great News! NICE: U-Turn on Treatment for Wet AMD. Available at: http://www.coventryblind.org.uk/great-news-nice-u-turn-treatment-wet-amd
6. A.S. Alving Enzymatic deficiency in primaquine sensitive erythrocytes Science 124 1956 484 485
7. E.A. Browne The inheritance of an intrinsic abnormality of the red blood cell predisposing to drug induced haemolytic anaemia Johns Hopkins Med. J. 101 1957 115 118
8. R.M. Weinshilboum, and S.L. Sladek Mercaptopurine pharmacogenetics: monogenic inheritance of erythrocyte thiopurinemethyltransferase activity Am. J. Hum. Genet. 32 1980 651 662 (Pubitemid 10061685)
9. S. Boyd Remarks on oophorectomy in cancer of the breast BMJ 2 1900 1161 1167
10. C.T. Beatson On treatment of inoperable cases of carcinoma of the mamma: suggestions for a new method of treatment with illustrative cases Lancet 2 1896 162 165
11. D. Slamon Human breast cancer: correlation of relapse and survival with amplification of the Her-2/Neu oncogene Science 235 1987 177 182 (Pubitemid 17231334)
12. Pharmacogenomics in oncology; Refection Paper from EMA. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/.WC500003866.pdf
13. MISG Personalised Medicine Forum report. Fifth Forum of the Ministerial Industry Strategy Group (MISG) - 9 October 2009: MHRA. Regulatory aspects
14. EPAR. European Medicines Agency - Tarceva
15. The Medicines Act 1968, Legislation.gov.uk
16. EEC Directive 65/65/EEC. OJ L, 22 of 9.2.1965, p. 369
17. C.D. Furberg, and B. Pitt Withdrawal of cerivastatin from the market Curr. Control Trials Cardiovasc. Med. 2 2001 205 207
18. IRESSA EPAR. http://www.ema.europa.eu/docs./WC500036361.pdf
19. S. Sanderson How can the evaluation of genetic tests be enhanced? Lessons learned from the ACCE framework and evaluating genetic tests in the United Kingdom Genet. Med. 7 2005 495 500 (Pubitemid 41445490)
20. HercepTest IFU, p. 25. Available at: http://www.dako.com/uk/download.pdf? objectid=120856003